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Generated: October 22, 2018

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Cysteamine bitartrate - Generic Drug Details

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What are the generic sources for cysteamine bitartrate and what is the scope of cysteamine bitartrate patent protection?

Cysteamine bitartrate is the generic ingredient in two branded drugs marketed by Horizon Pharma Usa and Mylan, and is included in two NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for cysteamine bitartrate. Three suppliers are listed for this compound.

Pharmacology for cysteamine bitartrate
Synonyms for cysteamine bitartrate
(+/-)-Tartaric Acid
(Mercaptoethyl)ammonium hydrogen tartrate
2-aminoethanethiol 2,3-dihydroxysuccinate
2-aminoethanethiol dihydrogen 2,3-dihydroxybutanedioate
2-aminoethanethiol; 2,3-dihydroxybutanedioate
27761-19-9
AC1L4POT
AC1Q5BFD
AKOS024332936
BC245627
C4H6O6.C2H7NS
CHEBI:50386
CHEMBL2062263
CTK4G0224
EINECS 248-641-7
FT-0696891
LS-174194
MCULE-1129308393
Mercamine bitartrate
Mercaptoethylamine bitartrate
SCHEMBL49513

US Patents and Regulatory Information for cysteamine bitartrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Horizon Pharma Usa PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-002 Apr 30, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Horizon Pharma Usa PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-002 Apr 30, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Horizon Pharma Usa PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-001 Apr 30, 2013 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Horizon Pharma Usa PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-001 Apr 30, 2013 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Horizon Pharma Usa PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-002 Apr 30, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Horizon Pharma Usa PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-001 Apr 30, 2013 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Horizon Pharma Usa PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-002 Apr 30, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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International Patents for cysteamine bitartrate

Supplementary Protection Certificates for cysteamine bitartrate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0649 Netherlands ➤ Try a Free Trial PRODUCT NAME: CYSTEAMINE; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130910
2014 00013 Denmark ➤ Try a Free Trial PRODUCT NAME: CYSTEAMIN, HERUNDER MERCAPTAMINBITARTRAT; REG. NO/DATE: EU/1/13/861 20130906
2014000023 Germany ➤ Try a Free Trial PRODUCT NAME: CYSTEAMIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/861 20130906
4 50001-2014 Slovakia ➤ Try a Free Trial PRODUCT NAME: MERKAPTAMIN; FIRST REGISTRATION: EU/1/13/861, 20130906
00649 Netherlands ➤ Try a Free Trial PRODUCT NAME: CYSTEAMINE; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130906
/2014 Austria ➤ Try a Free Trial PRODUCT NAME: CYSTEAMIN; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130910
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Medtronic
Cipla
US Army
Daiichi Sankyo
Baxter
Accenture
McKinsey
Mallinckrodt

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